WO2014164496A1 - Bobine d'embolisation détachable, enroulée, plate - Google Patents

Bobine d'embolisation détachable, enroulée, plate Download PDF

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Publication number
WO2014164496A1
WO2014164496A1 PCT/US2014/022590 US2014022590W WO2014164496A1 WO 2014164496 A1 WO2014164496 A1 WO 2014164496A1 US 2014022590 W US2014022590 W US 2014022590W WO 2014164496 A1 WO2014164496 A1 WO 2014164496A1
Authority
WO
WIPO (PCT)
Prior art keywords
coil
flat wire
coil assembly
detacher
tether
Prior art date
Application number
PCT/US2014/022590
Other languages
English (en)
Inventor
Steven J. Ferry
DeLois Marie FERRY
Original Assignee
Ferry Steven J
Ferry Delois Marie
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ferry Steven J, Ferry Delois Marie filed Critical Ferry Steven J
Priority to US14/774,787 priority Critical patent/US20160022271A1/en
Publication of WO2014164496A1 publication Critical patent/WO2014164496A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/12031—Type of occlusion complete occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00836—Material properties corrosion-resistant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00876—Material properties magnetic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12068—Details concerning the detachment of the occluding device from the introduction device detachable by heat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12086—Details concerning the detachment of the occluding device from the introduction device magnetically detachable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/1209—Details concerning the detachment of the occluding device from the introduction device detachable by electrical current or potential, e.g. electroactive polymer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/36—Materials or treatment for tissue regeneration for embolization or occlusion, e.g. vaso-occlusive compositions or devices

Definitions

  • Inventive subject matter disclosed herein relates to a flat wire palladium (Pd) embolization coil for occluding malformations within the human vasculature.
  • the prior art includes methods for occluding vessel openings.
  • the methods are catheter based and employ a very thin wall compliant balloon on a distal tip of the catheter to achieve occlusion. These devices also require the use of a guidewire to track to a desired location.
  • the thin wall when the distal balloon is inflated with contrast media, the balloon is susceptible to rupture as well as being susceptible to rupture in use.
  • the coil assembly includes a flat wire coil comprising Palladium and or Platinum in a thickness and width ranging from 0.0005 inches by 0.003 inches coiled to a pitch of 0.000 to 0.012 inches, a cut width in a range 0.0001 to 0.005 inches and a length of 10 cm to 90 cm, having an inner diameter in a range from of 0.004 to 0.0016 inches and an outer diameter within a range of 0.006 to 0.018 inches.
  • the coil assembly also includes a detacher that is detachably attachable to the flat wire coil.
  • Inventive subject matter also includes a coil assembly for treating a vascular malformation.
  • the coil assembly includes a flat wire coil comprising Palladium or other such metal, having an optimum packing density, coiled to a pitch of 0.001 inches, a cut width of 0.0007 inches and a length of 90 cm, having an inner diameter of 0.012 inches and an outer diameter within a range of 0.006 to 0.018 inches.
  • the coil assembly also includes a detacher that is detachably attachable to the flat wire coil.
  • Figure 1 illustrates a side view of a coil for treating a vessel malfunction.
  • Figure 1 A illustrates a side view of another embodiment of a distal coil segment.
  • Figure IB illustrates a side view of a safety tether of Figure 1.
  • Figure 1C illustrates a longitudinal cross-sectional view of a mechanical detachment system for a coil for treating a vessel malfunction.
  • Figure 2 A illustrates a side cross-sectional view of a mechanical detachment system for the coil of Figure 1.
  • Figure 2B illustrates a side cross-sectional view of a mechanical detachment system for the coil of Figure 1.
  • Figure 3 illustrates a side cross-sectional view of a mechanical detachment system for the coil of Figure 1.
  • Figure 4A illustrates a side cross-sectional view of a magnetic detachment system for the coil of Figure 1 when magnets have no current passing through them.
  • Figure 4B illustrates a side cross-sectional view of a magnetic detachment system for the coil of Figure 1 when current passes through a tether magnet.
  • Inventive embodiments disclosed herein include a coil assembly
  • the coil assembly 10 that includes a detachable coil 20 and pusher assembly 12, such as is shown in Figures 1 and 1A, effective for use in the treatment of vascular malformations such as, but not limited to, cerebral aneurysms and the like.
  • Said coil assembly 10 has an outer diameter ranging from 0.006" to 0.018".
  • the coil assembly 10 includes a distal tip 23 and a proximal end 13.
  • the distal tip 23 of the coil assembly device 10 is part of the detachable distal coil 20, shown in Figures 1 and 1A.
  • the detachable coil 20 is fabricated with flat wire at a specified pitch and gap specification.
  • a safety tether 15 extends from the distal tip 23 to proximal end 21 of the detachable coil 20. The tether 15 prevents the detachable coil 20 from unwinding if it becomes caught.
  • a detachment point 19 is positioned into the proximal end 21 of the coil body 20 and distal end 16 of the pusher 12.
  • detachment is achieved by conventional inductive heating to melt a polymer tether, or magnetic detachment or mechanical detachment. The mechanical and magnetic systems are discussed herein.
  • the pusher assembly 12 is connected to the detachable coil 20 which is used to provide axial force for the delivery of the detachable coil 20 to a desired location in a living being. It is believed that by using the flat wire configuration, the detachable coil 20 is positioned in such a manner while being deployed so as to improve the packing density of the deployed coil as compared to conventional round wire GDC coils.
  • Figure 1 is configured with the pusher assembly 12 having an outer tube within which a tether tube 15 is placed.
  • a flanged retainer 18 with an inner diameter is positioned into the end 16 of the tether tube 15 and affixed in an appropriate manner known in the art. See (A- A) and (B-B) in Figures 1C and 2B.
  • the flanged retainer 18 is affixed to the detachable coil body 20, having proximal end 21 and distal end 23.
  • proximal end 21 of the detachable coil body 23 is an assembly that includes a cylindrical marker 22 into which a smaller canister 24 with a septum 26 is placed so as to allow the septum 26 to be facing the flanged retainer 18.
  • a secure joint is formed, as shown in Figure 2B.
  • the pusher tube 12 is held and a tether actuator dial 30 is rotated from its locked position and the flanged retainer 18 is withdrawn proximately through the septum 26, thereby releasing the detachable coil 20 from the pusher assembly 12, as shown in Figure 3.
  • a new coil may now be placed on the coil assembly 10 in the same manner.
  • the flanged retainer tube is bonded into place at the proximal end of the detachable coil, using the appropriate material. Detachment occurs, when the canula tube is used to buttress the detachment point of the coil while the tether tube is withdrawn resulting in separation. Then, the entire pusher assembly is removed from the microcatheter leaving the coil in the desired location.
  • the flanged retainer can be mounted to a catheter or microcatheter or mounted to be integral a solid round wire as well.
  • the illustration provided in Figure 3 shows a tubular design.
  • the detachable coil body has a pitch of 0.001 inches, a cut width/thickness of 0.0007 inches, a length of 90 cm, an inner diameter of 0.012 inches and an outer diameter of 0.0135 inches.
  • the wire was a Pd flat wire, 304V SST flat wire (O.OOlin. to 0.003 in.) In one embodiment, the wire has rounded edges.
  • Figure 4 employs a small magnet 42 encapsulated and mounted to a distal end 44 of a tether tube 46.
  • a second sealed magnet 44 is placed within a proximal end of a coil body 48, as shown in Figure 5.
  • Detachment can be achieved by either employing a current supplied to the tether magnet 42 in order to alter the polarity, whereby matching the same polarity on both magnets (++ or— ) 42 and 44 resulting in repulsion and separation. See (C-C) in Figure 4 .
  • magnet canisters can be assembled in the same manner, however a cylindrical magnet has a (++) half and a (- -) half.
  • the coil 48 is detached by incorporation of two small magnets 42 and 44 in the proximal end of the coil 48 and the distal mating end
  • Said magnets 42 and 44 are encapsulated in a biocompatible material to ensure biocompatibility and stability. Detachment occurs by applying a current and changing the polarity on the tether side magnet 42, whereby resulting in same polarity and repulsion, thus separation of the coil48 from the pusher.50. It should be noted that the magnets
  • Magnetic polarity is changed in the wire magnet mechanically as well. Magnetic polarity is changed by using a magnet tipped tether which runs the length of the pusher and which has an actuator that allows the user to rotate the magnet tipped cannula and changing the polarity of the tether magnet, thus again attaining separation, as shown in Figure 5 at (D-D).
  • Rotational direction of actuator dial 60 may be clockwise or could be counter clockwise
  • Embodiments disclosed herein include a flat wound coil design, wherein coiling is achieved on the flat of the wire or on the edge, both providing different characteristics to the respective coils.
  • the device has an improved packing density as a result of the ribbon like coil. Given the thin thickness of the coil, the coil compresses providing greater capacity for additional material.
  • the device employs flat wire of pure Palladium (Pd), understanding that purity at its best is 99.995 percent in natural ore.
  • Some device embodiments employ aPd/Ti alloy, which has good radiopacity at a lower cost than Pt material. Ti at a fractional concentration.
  • the flat wire configuration has a greater surface area that conventional round wire.
  • the flat wire may be precoated prior to coiling to improve platelet aggregation.
  • Magnetic detachment eliminates a need for an inductive detachment system.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Reproductive Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Epidemiology (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un ensemble bobine pour traiter une malformation vasculaire, comprenant: une bobine en fil méplat comprenant du palladium, présentant une masse volumique apparente optimale, qui est enroulé et qui est peut être fixé détachable à la bobine en fil méplat.
PCT/US2014/022590 2013-03-11 2014-03-10 Bobine d'embolisation détachable, enroulée, plate WO2014164496A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US14/774,787 US20160022271A1 (en) 2013-03-11 2014-03-10 Flat wound detachable embolization coil

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361776465P 2013-03-11 2013-03-11
US61/776,465 2013-03-11

Publications (1)

Publication Number Publication Date
WO2014164496A1 true WO2014164496A1 (fr) 2014-10-09

Family

ID=51658887

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2014/022590 WO2014164496A1 (fr) 2013-03-11 2014-03-10 Bobine d'embolisation détachable, enroulée, plate

Country Status (2)

Country Link
US (1) US20160022271A1 (fr)
WO (1) WO2014164496A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3340893A1 (fr) * 2015-08-25 2018-07-04 Endoshape, Inc. Manchon pour la pose de spire métallique pour embolisation

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US5941888A (en) * 1998-02-18 1999-08-24 Target Therapeutics, Inc. Vaso-occlusive member assembly with multiple detaching points
US20040199175A1 (en) * 2003-04-03 2004-10-07 Scimed Life Systems, Inc. Flexible embolic device delivery system
US20060276827A1 (en) * 2005-06-02 2006-12-07 Vladimir Mitelberg Stretch resistant embolic coil delivery system with mechanical release mechanism
US20070142859A1 (en) * 2005-12-19 2007-06-21 Boston Scientific Scimed, Inc. Embolic coils
US20120259354A1 (en) * 2008-10-13 2012-10-11 Stryker Nv Operations Limited Vaso-occlusive coil delivery system

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US5108407A (en) * 1990-06-08 1992-04-28 Rush-Presbyterian St. Luke's Medical Center Method and apparatus for placement of an embolic coil
US5234437A (en) * 1991-12-12 1993-08-10 Target Therapeutics, Inc. Detachable pusher-vasoocclusion coil assembly with threaded coupling
US5250071A (en) * 1992-09-22 1993-10-05 Target Therapeutics, Inc. Detachable embolic coil assembly using interlocking clasps and method of use
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US5582619A (en) * 1995-06-30 1996-12-10 Target Therapeutics, Inc. Stretch resistant vaso-occlusive coils
US5964797A (en) * 1996-08-30 1999-10-12 Target Therapeutics, Inc. Electrolytically deployable braided vaso-occlusion device
US6346091B1 (en) * 1998-02-13 2002-02-12 Stephen C. Jacobsen Detachable coil for aneurysm therapy
US6296622B1 (en) * 1998-12-21 2001-10-02 Micrus Corporation Endoluminal device delivery system using axially recovering shape memory material
US6102932A (en) * 1998-12-15 2000-08-15 Micrus Corporation Intravascular device push wire delivery system
US6179857B1 (en) * 1999-02-22 2001-01-30 Cordis Corporation Stretch resistant embolic coil with variable stiffness
US6280457B1 (en) * 1999-06-04 2001-08-28 Scimed Life Systems, Inc. Polymer covered vaso-occlusive devices and methods of producing such devices
US6790218B2 (en) * 1999-12-23 2004-09-14 Swaminathan Jayaraman Occlusive coil manufacture and delivery
ES2391763T3 (es) * 2000-04-07 2012-11-29 Collagen Matrix, Inc. Dispositivo de embolización
US20030120302A1 (en) * 2001-12-20 2003-06-26 Scimed Life Systems, Inc. Vaso-occlusive device with serpentine shape
JP4602080B2 (ja) * 2002-07-25 2010-12-22 ボストン サイエンティフィック リミテッド 人体構造内を進行する医療用具
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Publication number Priority date Publication date Assignee Title
US5941888A (en) * 1998-02-18 1999-08-24 Target Therapeutics, Inc. Vaso-occlusive member assembly with multiple detaching points
US20040199175A1 (en) * 2003-04-03 2004-10-07 Scimed Life Systems, Inc. Flexible embolic device delivery system
US20060276827A1 (en) * 2005-06-02 2006-12-07 Vladimir Mitelberg Stretch resistant embolic coil delivery system with mechanical release mechanism
US20070142859A1 (en) * 2005-12-19 2007-06-21 Boston Scientific Scimed, Inc. Embolic coils
US20120259354A1 (en) * 2008-10-13 2012-10-11 Stryker Nv Operations Limited Vaso-occlusive coil delivery system

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